Terms of Reference

The working group is tasked to review the evidence with respect to the following questions/issues and to propose to SAGE recommendations, including the need to update recommendations stated in the current (2012) hepatitis A vaccine position paper.

Hepatitis A vaccine position paper

1. Review data regarding the global prevalence and burden of disease caused by hepatitis A virus infection, including outbreaks.
2. Identify a global list of inactivated and live attenuated hepatitis A vaccines that are being used in public health programmes.
3. Review data on efficacy, effectiveness, duration of protection, schedules, safety, and cost-effectiveness of internationally available hepatitis A vaccines, considering all dosing and schedules in particular single dose schedules of inactivated vaccine.
4. Review programmatic and feasibility of introduction into risk-based vaccination and routine immunization schedule.
5. Consider an update to the 2012 WHO position paper on hepatitis A vaccines.

Composition

SAGE Members

• Rakesh Aggarwal (Chair of the working group) Jawaharlal Institute of Postgraduate Medical Education and Research, India.
• Shabir Mahdi, University of the Witwatersrand, South Africa

Experts

• Zhijie An, Chinese Center for Disease Control and Prevention, China
• Fuqiang Cui, Peking University, China
• Manal Hamdy El Sayed, Ain Shams University, Egypt
• Jorge Enrique Gonzalez, National Administration for Laboratories and Institutes of Health, Argentina
• Sema Mandal, Public Health England, UK
• Kassiani Mellou, Hellenic Public Health Organization, Greece
• Noele Nelson, Centers for Disease Prevention and Control, USA
• Thomas Wierzba, Wake Forest School of Medicine, USA

WHO secretariat

• Christoph Steffen (Immunization, Vaccines and Biologicals)
  
• Shalini Desai (Immunization, Vaccines and Biologicals)
  
• Alba Vilajeliu (PAHO)
• Tigran Avagyan (WPRO),
• Julien Kabore (AFRO)
• Olufunmilayo Lesi (Global Hepatitis Programme)
  

Declarations of Interest

All members completed a declaration of interests form. One SAGE members and three Working Group members reported relevant interests. All interests were assessed not to constitute a conflict of interest. It was concluded that all members could take part in full in all of the proceedings of the Working Group. The reported relevant interests are summarized below:

SAGE members

Shabir Madhi

• Serves as a member of the International Vaccine Institute (IVI) Scientific Advisory Committee. This interest was assessed as non-personal, non-specific and financially insignificant*.
• Serves as a member of the BMGF Global Health Scientific Advisory Committee. This interest was assessed as non-personal, non-specific and financially significant*.
• Served as advisor to the Pfizer Group B streptococcal (GBS) vaccine program until 2017. This interest was assessed as non-personal, non-specific and financially insignificant*.
• Serves as a member of the DSMB of GSK on porcine-free rotavirus vaccine. This interest was assessed as non-personal, non-specific and financially insignificant*.
• Serves as a member of the DSMB of Janssen on inactivated polio vaccine. This interest was assessed as non-personal, specific and financially insignificant*.
• Serves as a member of the DSMB of CAPRISA on a HIV monoclonal antibody. This interest was assessed as non-personal, non-specific and financially insignificant*.
• His institution receives grants from Pfizer on a GBS vaccine clinical trial and GBS epidemiology study on correlate of protection. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received grants from Novartis and GSK support on GBS epidemiology until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives grants from BMGF on epidemiology studies of GBS and pneumococcus, and clinical trials on PCV. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received a grant from VPM /Serum Institute regarding a clinical trial on tuberculosis until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received a grant from Medimmune regarding clinical trials on RSV monoclonal antibody until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives a grant from Novovax regarding a clinical trial on maternal RSV vaccine program. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives a grant from Mitsubishi regarding a clinical trial on rotavirus vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received a grant from MSD in February 2019 regarding a clinical trial on monoclonal RSV antibody. This interest was assessed as non-personal, non-specific and financially significant*.

Working Group members

Zhijie An

• Served as co-principal investigator on a phase IV immunogenicity study on a measles and rubella combined vaccine, and Japanese encephalitis vaccine funded by US CDC. This interest was assessed as non-personal, non-specific and financially insignificant*.
• Serves as principal investigator on a phase IV immunogenicity study on a polio vaccine funded by WHO. This interest was assessed as non-personal, non-specific and financially insignificant*.
• Serves as co-principal investigator on a phase IV Enterovirus (EV71) vaccine funded by the Chinese government. This interest was assessed as non-personal, non-specific and financially insignificant*.

Sema Mandal

• Serves on the Viral Hepatitis Prevention Board (VHPB). This interest was assessed as non-personal, specific and financially insignificant*.

Manal Hamdy El-Sayed

• Participation as a panelist in an webinar in collaboration with the World Hepatitis Alliance and Abbott on the World Hepatitis Day (Hepatitis 2030 Agenda- How Africa can Tackle the silent killer). This interest was assessed as non-personal, non-specific and financially insignificant*.

* According to WHO's Guidelines for Declaration of Interests (WHO expert), an interest is considered "personal" if it generates financial or non-financial gain to the expert, such as consulting income or a patent. "Specificity" states whether the declared interest is a subject matter of the meeting or work to be undertaken. An interest has "financial significance" if the honoraria, consultancy fee or other received funding, including those received by expert's organization, from any single vaccine manufacturer or other vaccine-related company exceeds 10,000 USD in a calendar year. Likewise, a shareholding in any one vaccine manufacturer or other vaccine-related company in excess of 1,000 USD would also constitute a “significant shareholding”.